BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIONEER PLUS CATHETER

    MDR report key: 2890495 · Received December 31, 2012

    Report

    Report Number
    1220452-2012-00075
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    November 28, 2012
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DQY
    PMA / PMN Number
    K101777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. THEREFORE, AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CAN NOT BE PERFORMED. THE LOT NUMBER FOR THE DEVICE IS UNKNOWN AND THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD CAN NOT BE PERFORMED. IF IN THE FUTURE ANY ADDITIONAL INFORMATION OR THE ACTUAL COMPLAINT SAMPLE IS RETURNED A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. THE ANALYSIS IS COMPLETE AS OF TODAY (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE DISCREPANT DEVICE IS NOT POSSIBLE, DEVICE DISCARDED NOT RETURNING. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW- UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CATHETER WAS UP AND OVER A .014" WIRE. THE VESSEL WAS CALCIFIED AND INITIALLY THE DOCTOR TRIED TO PULL BACK ON CATHETER AND THE WIRE BROKE OFF LEAVING SOME IN THE PATIENT. HE THEN TRIED TO SNARE FROM ABOVE AND COULD NOT DO IT. HE PULLED ON THE CATHETER AND THE TRANSDUCER TIP BROKE OFF. HE TRIED TO SNARE BUT PATIENT WENT TO SURGERY. THE PATIENT DID FINE AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIONEER PLUS CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1